Automated prior authorization for genetic efficacy testing with presciption dispensation

ABSTRACT

System and methods for automating preauthorization of genetic efficacy testing with prescription dispensation are provided. Coverage requests for medicines are received from pharmacy systems. Databases are queried to retrieve policy rules for the coverage requests. A coverage decision analysis is performed and where an associated medication is otherwise approved for coverage and where genetic efficacy testing is available for the associated medication, a prior authorization for such genetic efficacy testing is automatically generated and included with which is transmitted together with an approval of coverage decision to a requesting one of said number of pharmacy systems.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation-in-part of U.S. application Ser. No.17/179,870 filed Feb. 18, 2021, which is a continuation-in-part of U.S.application Ser. No. 16/945,198 filed Jul. 31, 2020 (the “'198Application”), which is a continuation-in-part of U.S. application Ser.No. 16/848,504 filed Apr. 14, 2020 (the “'504 Application”), which is acontinuation-in-part of U.S. application Ser. No. 16/674,189 filed Nov.5, 2019 (the “'189 Application”), which is a continuation-in-part ofU.S. application Ser. No. 16/441,597 filed Jun. 14, 2019 (the “'597Application”), which claims the benefit of U.S. Provisional ApplicationSer. No. 62/685,479 filed Jun. 15, 2018 and U.S. Provisional ApplicationSer. No. 62/773,424 filed Nov. 30, 2018. This application is also acontinuation-in-part of the '198 Application. This application is also acontinuation-in-part of the '504 Application. This application is also acontinuation-in-part of the '189 Application. This application is also acontinuation-in-part of the '597 Application. The disclosures of each ofthe foregoing are hereby incorporated by reference as if fully restatedherein.

TECHNICAL FIELD

Exemplary embodiments relate generally to systems and methods forproviding automated prior authorization for genetic efficacy testing,such as with dispensation of a pharmaceutical.

BACKGROUND AND SUMMARY OF THE INVENTION

A person visiting a doctor may present with one or more symptoms. Basedon the symptoms presented, test results, or underlying conditions ordiseases diagnosed, the person may be prescribed one or more medicationsor other treatment options by the healthcare provider as part of atreatment program. These treatments may be selected based on thehistorical effectiveness of such treatment options against the symptomspresented by the person and/or the underlying disease(s) or condition(s)diagnosed by the healthcare provider. Traditionally, the prescription oftreatment options is, at least initially, based on historicaleffectiveness of certain medications against the diagnosed disease.Individual prescriptions may be altered through a trial and errorprocess following the initial prescription. For example, alternativemedications, dosages, or other treatments (e.g., surgery, herbalremedies, other therapies) may be prescribed where the prescription of aparticular treatment option causes a side effect or allergic reaction ina patient and/or simply fails to achieve the desired outcome. Overprescription or dosing of treatments, particularly of medications, maycause side effects or other undesirable consequences. Under prescriptionor dosing of treatments, particularly of medications, may bring aboutineffective results, side effects, or other undesirable consequences.

A person's genetic makeup often affects how the person responds tocertain medical treatments, such as the administration of medications.For example, a person's genetic makeup may cause some medications ordosages to be wholly or partially ineffective. As used herein, the termineffective may be understood to mean wholly or partially ineffective.As a further example, a person's genetic makeup may make surgery more orless desirable. Prescription of treatments to a person who has a geneticmakeup that makes the treatment wholly ineffective may waste resourcesand unnecessarily expose the person to the risk of side effects.Similarly, prescription of treatments to a person who has a geneticmakeup that makes the treatment partially ineffective may result in lessthan desirable therapeutic effects, require a larger dosage, or the liketo be effective. In some cases, alternative medications, dosages, orother treatment options are available for use with the same, or similar,therapeutic effects.

For example, without limitation, a blood thinner may be known to reducethe risk of embolisms and may be prescribed to a person following stentplacement. However, the patient's individual genetic makeup orphysiology may alter the effectiveness of the prescribed blood thinner.For example, without limitation, the blood thinner may have a reducedeffectiveness in persons carrying specific genetic markers. It would bedesirable to substitute alternative medications or adjust the dosage ofprescribed medications for persons having a genetic makeup which reducesthe effectiveness of the prescribed medication. As a further example,again without limitation, the prescribed blood thinner may be whollyineffective in persons carrying specific genetic markers. It would bedesirable to substitute alternative medications, or find alternativetreatment options, for persons having a genetic makeup which renders theprescribed medication ineffective. Therefore, what is needed is a systemand method for determining the effectiveness of medications usinggenetics.

A persons' genetic makeup may determine the efficacy of other treatmentsbeyond just medications. For example, without limitation, a persons'genomic makeup may be analyzed to determine the efficacy of variouscancer treatment options. Such options may include various medications,such as chemotherapy, but may also include surgery, radiation, activesurveillance, and other treatment approaches.

Current systems, such as electronic medical record systems (“EMRs”), areoften unable to accept genomic information in a meaningful way and/orlack a dedicated space for such genetic information. For example, EMRsoften do not have a designated page, portal, display, or the like forgenomic testing results to be displayed. Therefore, what is needed is asystem and method for integrating genetic efficacy information withexisting systems.

Being a cutting-edge field, genomics testing is often not part of ahealthcare provider's routine care plan. A healthcare provider may noteven be aware that certain genomic testing is available that candetermine the efficacy of various treatment options, such asmedications. Therefore, what is needed is a system and method fordetermining eligibility for genetic efficacy testing.

These disclosures provide systems and methods for determining theeffectiveness of treatment options, such as medications, using geneticdata. A user's visit information may be reviewed to identify applicabletests. For example, such tests may indicate the presence or non-presenceof genetic markers which may indicate a genetic makeup for a patientthat may have a bearing on the effectiveness of one or more treatmentsprescribed, and/or likely to be prescribed, to the user.

The disclosed systems and methods may be applied to any number ofgenomic efficacy tests. For example, without limitation, genomic testingmay be ordered to determine the patient's likelihood of developingcertain cancers and/or the efficacy of various treatment options fordifferent types of cancer.

The disclosed systems and methods may streamline the ordering andeligibility process. The system may be configured to determine whetheridentified tests fit certain billing parameters. For example, the systemmay be configured to determine whether the identified tests are coved bythe user's insurance. If the test for one or more markers does not fitthe billing parameters, then the next genetic marker(s) may beconsidered. If the test does fit the billing parameters then the optionto order testing may be presented to the healthcare provider. Ifselected, the appropriate marker(s) may be added to a testing device andthe genetic testing may be performed. In exemplary embodiments,diagnostic and treatment codes may be entered by the healthcare providerinto their system. A determination may be made as to whether certaingenetic efficacy testing meets various insurance eligibility criteria,such as but not limited to, medically necessary criteria. If so, therespective genomic tests may be automatically added to an order list. Inthis way, all available testing for which the patient is eligible may beautomatically added to an ordering list, thereby increasing theavailability of potentially relevant information to the healthcareprovider. The order list may be subsequently displayed to the healthcareprovider for confirmation, though in other exemplary embodiments theorder list may be automatically processed.

To perform the testing, genetic material may be removed from the user. Atesting device may be created to test for the specific genetic marker(s)ordered. The genetic material may be sequenced using the testing deviceand the presence or non-presence of the tested genetic markers may bedetermined. The results may be analyzed and ineffective treatmentoptions, such as but not limited to medications, may be identified. Inexemplary embodiments, for each treatment prescribed or likely to beprescribed, the presence or non-presence of one or more genetic markersmay be analyzed and compared against the treatments known to beeffective or ineffective in the presence of the given marker. Effectivetreatments and/or dosages may be identified. Alternatively, oradditionally, ineffective treatments and/or dosages may be identified.For those treatments and/or dosages determined to be ineffective,alternative medications, dosages, and/or treatment options may besuggested.

Integration into existing EMRs, electronic health records (“EHR”), andother healthcare provider systems may be performed by designatingineffective medications or other treatment options as an allergy in theuser's file. This may provide a pathway for integration with existingEMRs, EHRs, and other healthcare provider systems. Advantageously, inexemplary embodiments, this solution may configure the EMR, EHR, orother healthcare provider system to generate an alert upon selection ofa medication or other treatment options designated by the testingresults to be ineffective. In this way, the disclosed systems andmethods may be integrated within the framework of existing systems toprevent the costs and complexities of redesigning the existing systems.

Regardless, the testing results may be returned to the healthcareprovider's system. For example, treatment of a particular disease maynormally first begin with medication. However, if the person has agenetic makeup which would make such medication ineffective, a surgicaloption may instead be suggested.

The results may be returned to the healthcare provider in the form of aninterface for display on an electronic display. The results may bedisplayed in a fashion which provides the clinical consequences ofprescribing the treatment. The interface may further provide indicationsof particular conditions and generate alerts when particular conditionsare met. For example, without limitation, executable softwareinstructions may be provided which configure the electronic display todisplay an interface comprising an explanation of the results, alerts,abnormal ranges, ineffective treatments, potential interactions asunderstood in view of the analyzed genetic information, and otherclinical information. This information may be transmitted with theresults in a single file.

In exemplary embodiments, these results and alerts may be integratedinto the healthcare providers' EHR by way of a single file, thoughmultiple files may be utilized. In exemplary embodiments, the results ofthe ordered tests, including but not limited to the ineffectivetreatment options, may be transmitted to a healthcare informationexchange (“HIE”). The HIE may subsequently distribute the results to anumber of linked healthcare provided systems and/or make such dataavailable for access. This information may be further transmitted to anynumber of healthcare provider facilities, such as but not limited tohospitals, by way of one or more HIEs. For example, information may betransmitted to all healthcare providers treating the user. The resultsmay also be stored for use by, and selective transmission to, futurehealthcare providers. In this way, the disclosed systems and methods mayintegrate with existing healthcare provider systems, such as EHRs andHIEs to facilitate the ordering of such genomic efficacy tests andintegrate the results into the framework of existing systems.Furthermore, integration with a number of healthcare provider systemsmay be accomplished by integration with one or more HIEs.

Genetics testing, such as but not limited to genetics-based medicationefficacy testing, is a burgeoning field. Not all payors support genetictesting, and those that do often have specific rules regarding whichtypes of testing are covered and which are not. Conventionally, todetermine if the genetic testing will be covered, a representative of ahealthcare provider's office contacts a patient to obtain certaininformation, which is then passed to the payor for prior authorizationof the proposed genetic tests. This work is taxing on patients andhealthcare provider office staff. It also results in duplicateinformation being generated for prior authorization purposes andlaboratory ordering purposes. Furthermore, the patient sometimes owes acopay, and the healthcare provider's office is further burdened withcollecting payment from the insured, paying the laboratory for testing,and collecting amounts owed from the patient. This results in complexmanagement and transfer of funds.

Laboratories typically do not have sufficient information or resourcesto perform the prior authorization request. For example, withoutlimitation, the laboratory may not have access to the patient's healthhistory such as but not limited to disease diagnosis and activemedications, which are sometimes required to determine if the orderedgenetic testing is medically necessary. Therefore, what is needed is asystem and method for laboratory-based authorization of genetic testing.

Systems and methods for automatically providing laboratory-basedauthorization of genetic testing are provided. An order may be generatedat a healthcare provider's EHR or other system. The order may beinitiated by a healthcare provider and may be based on suggested ordersfrom the laboratory. A specimen for testing may be sent from thehealthcare provider to the laboratory. The order information may be sentelectronically from the healthcare provider's office system or EHR to alaboratory information system (“LIS”) associated with a laboratory. TheLIS may automatically parse information from the order. The LIS may bein electronic communication with the EHR and electronically retrievecertain patient health information.

The LIS may use the parsed order data and/or retrieved healthinformation to automatically generate an electronic prior authorizationrequests which may be electronically transmitted to the appropriateparty for communication and/or approval. The appropriate party mayinclude, for example without limitation, the payor, the call center, aprior authorization provider, some combination thereof, or the like. Theappropriate party may return a reference ID and a patient responsibilityamount. The patient responsibility may represent an amount owned by thepatient such as, but not limited, to a copayment, deductible,coinsurance, some combination thereof, or the like. If the patientresponsibility exceeds a predetermined threshold, a call center noticemay be automatically generated and transmitted to the laboratory and/ora call center. The call center and/or laboratory may contact the patientto obtain a virtual billing consent to proceed. The virtual billingconsent may be consistent with a signed informed billing consentpresented to the patient in the office at the time of the testing isordered and/or the genetic material is gathered. If consent is denied,or if a predetermined number of attempts are made to contact the patientwithout success, the specimen may be destroyed and the order terminated.If consent is received, payment may be collected, such as in real timewhen obtaining the virtual billing consent, and the testing may beallowed to proceed. If the patient responsibility is below thepredetermined threshold, testing may proceed. Testing results may begenerated and transmitted to the healthcare provider. In exemplaryembodiments, the prior authorization and virtual billing consent processmay be completed while the specimen is in transit to the laboratory.

While all types of genetic testing are contemplated, certain advantagesmay be realized in particular for genetics-based medication efficacytesting. For such testing, the LIS may query the EHR to obtain a list ofactive medications. Alternatively, or additionally, the LIS may querythe EHR to obtain a list of diagnoses and use that list to generate alist of medications likely to be prescribed to the patient. The efficacyof one or more of the listed medications may be tested. This same listof medications and/or diagnoses may be used in making priorauthorization decisions, for example without limitation, to determinewhich tests are medically necessary. Thus, in at least one embodiment,the invention improves the processing capabilities and speed byeliminating duplicate information and reducing burdens on electronicstorage.

Electronic funds management is another technological challenge. Underconventional approaches, the healthcare provider acts as a collector andpayor for the laboratory, whose is the driver of fees for the testing.By utilizing the laboratory to directly obtain prior authorization andcollects funds, the complexity and challenges of electronic fundsmanagement and transfer are significantly reduced or eliminated. Thismay reduce the number of potential security intrusion standpoints, thenumber of parties needing to secure financial information, the number offunds transfers, and the like. It also may place the collection risk onthe laboratory instead of the healthcare provider.

The disclosed systems and methods may reduce the number of humaninteractions required, thereby improving data processing times and/oraccuracy. The electronic automation may result in faster, more accurate,and more consistent data processing. The disclosed systems and methodsmay reduce the amount of paper transferred, data faxed, telephone callsmade, voicemails recorded, and the like, all of which may serve asadditional points to data intrusion. In this way, the communicationpipeline may be streamlined to reduce the number of access points andimprove data security. The disclosed systems and methods may reduce theneed for resources at the healthcare provider office reducing businesscosts and complexity.

It takes time to receive data, specimens, perform genetic efficacytesting, generate reports, notify healthcare providers, and then notifypatients of results. In some cases, this delay in time may be longenough that the patient may have already filled their prescriptionand/or begun using it. This results in wasted prescriptions, driving upcosts in the healthcare system. Therefore, what is needed is a systemfor preventing the coverage or fill of ineffective prescribedmedications based on genetic efficacy testing.

Systems and methods for preventing the coverage or fill of ineffectiveprescribed medications based on genetic efficacy testing are provided.Patent data received at the LIS may include prescription information. Anotification regarding ordered prescriptions flagged as ineffective maybe sent to a pharmacy benefits provider (“PBM”) which interfaces withthe pharmacy. The interfacing with a PBM is an effective way to reach alarge number of patients as it is common for a PBM to manage pharmacybenefits for a larger population of individuals. The notification mayindicate that one or more medications have been determined to beineffective based on the person's genetic makeup. Upon attempt toreceive insurance coverage for such ineffective medications, the PBM maynotify the pharmacy that coverage is denied and/or to not fill one ormore such prescriptions, thereby preventing the patient from everreceiving the medication and reducing costs. The notification mayindicate that one or more prescribed medications have been determined tobe effective based on the person's genetic makeup. Upon attempt toreceive insurance coverage for such effective medications, the PBM maynotify the pharmacy to proceed with filling one or more suchprescriptions, thereby reducing costs by ensuring only effectivemedications are filled. In other exemplary embodiments, a lack ofnotification after a period of time may be treated as an indication thatsuch prescribed medications are considered effective. The PBM may flagineffective medications as an allergy in the electronic file associatedwith patient. This may permit integration into existing systems and flagfuture attempts to prescribe and/or approve coverage for the medication.

Where one or more prescriptions are indicated as being ineffective, theLIS may be configured to supply alternative medications in thenotification which are effective based on the patient's genetic makeup.In such cases, the PBM may notify the pharmacy of such alternativeswhich may be presented to the patient for approval and/or filled. Thenotification may comprise the full report transmitted to the healthcareprovider's office, or may be a simplified version. In other exemplaryembodiments, the notification may be sent directly to a pharmacy.

The systems and methods shown and/or described herein may permit forvertical integration of laboratory testing results. For example, withoutlimitation, such testing results may be vertically integrated acrosspayor systems, PBM systems, laboratory systems, EHR systems, HIEsystems, pharmacy systems, some combination thereof, or the like.

The modern medical system typically involves a number of healthcareproviders in the treatment of a patient. For example, a patient may beseen by a primary healthcare provider, referred to a specialist, laterbe admitted to the hospital, then be admitted into hospice, just to nameone example of many. Each provider may record medical data, diagnosisconditions, evaluate symptoms, prescribe medical, and order test, justto name a few examples. The patient may also file claims for insurancecoverage for some or all such treatments, may request cost sharing, ormay request preauthorization for the same, to name some examples. It maybe desirable to update medical information for the patient across thesemany providers and/or coordinate payment and/or reimbursement for thesame.

The disclosed systems and methods are configured to facilitate theupdate of such medical information to some or all of the many providersand/or coordinate payment and/or reimbursement for the same. However,updates can get missed. The disclosed systems and methods enhancepatient updates in a manner which facilitates precision therapy, such asbut not limited to, by integrating genetic efficacy testing results andalerts, suggested genetic efficacy testing options, UTI/STI testingresults and alerts, women's health information, combinations thereof andthe like. In this way, appropriate testing may be suggested forordering, ineffective medications or treatments may be updated, relevantinformation may be provided, combinations thereof and the like. In someembodiments, such enhanced updates may be provided while alsocoordinating payment and/or reimbursement for the same.

Normally, it may take several days or more for a patient's medicalinformation to be transferred from one facility to another. For example,without limitation, when a patient is transferred from a hospital tohospice care. It may take several days for a patient's full records toarrive from other medical providers, obtain necessary insuranceapprovals, transfer prescriptions from pharmacies, combinations thereof,and the like. This may result in a gap in certain therapies for thepatient, which may be particularly difficult for patients in need ofpalliative care by way of non-limiting example.

The disclosed system and methods may provide for centralization ofrecords, updating across systems, and/or faster processing anddistribution of such information, resulting in precision therapy. Suchsystems and methods may be used with any number and/or type ofhealthcare providers. The updates and records transferred may beenhanced with further updates, including flagging ineffectivemedications as an allergy, suggested orders for genetic efficacytesting, combinations thereof, and the like.

Normally, prior authorization, when required, is requested before aprocedure is performed or a medication is dispensed. However, not allcustomers are aware of the need to apply for prior authorization beforeundertaking a procedure or picking up a medication. Sometimes, customersare manually alerted to such issues and healthcare provider offices ofpharmacy offices attend to such prior authorization request on behalf ofthe patient. These manual workflows are time and labor intensive forpatients, healthcare providers, and pharmacies.

Systems and methods are provided herewith which automate priorauthorization efforts for genetic efficacy testing, such as withdispensation of pharmaceuticals. Prior authorization may becomeincreasingly beneficial where genetic efficacy testing is available fora prescribed medication because genetic efficacy testing results maydetermine if the prescription would have any, or a lessened, effect in aparticular patient. However, such genetic efficacy testing may take timeand, particularly in the case of pharmaceuticals, it may be advantageousto first dispense a medication, so as to potentially begin treatment(assuming the medication is effective) and then go about geneticefficacy testing process for such medications. Once testing results arereceived, a determination can be made if further dispensation makessense. In this manner, the patient may begin taking a prescribedmedication while testing is completed so as to not delay the treatmentprocess.

In exemplary embodiments, coverage requests for medications may bereceived at a pharmacy, PBM, and/or other payor system. The payor systemor a laboratory information system (“LIS”) may be configured to queryone or more databases regarding policy information for the patient andmedication. At the same time, or if the medication is otherwise approvedfor coverage, the payor system or the LIS may be configured to query thesame or different database(s) for testing information related to themedications for which coverage is requested. The results of the querymay identify which, if any, of the queried medications are associatedwith available genetic efficacy testing. In such cases, the payor systemmay be configured to generate an approval of coverage decision for themedication and automatically generate a prior authorization for theassociated genetic efficacy testing. The payor system or LIS may beconfigured to transmit the same to the pharmacy system such that theprescription may be filled and dispensed with notice of the priorauthorization.

The prior authorization may be valid for a time period, such as 60 daysfor example without limitation, and/or a number of refills, such as 3refills for example without limitation. If the payor system or LIS doesnot receive confirmation of performance of the genetic efficacy testingin the prior authorization by that time, the payor system or LIS may beconfigured to deny further refills and/or future fills of themedication, such as under a subsequent prescription, until such testingis completed. If the testing is completed, approval for further refillsand/or fills may be dependent on the results of the efficacy testing,such as is shown and/or described herein.

In this manner, a limited amount of medication may be preliminarilyreleased to the patient to begin treatment, and if that medication isdeemed undereffective or ineffective, further coverage approvals may bedenied and/or the patient may be switched to alternative medication(s)which may be more effective for the patient. Testing and/or resultsprocessing may be as shown and/or described herein. If the medication isnot otherwise approved for coverage, the payor system and/or LIS may beconfigured to transmit a denial of coverage decision to the pharmacysystem.

Further features and advantages of the devices and systems disclosedherein, as well as the structure and operation of various aspects of thepresent disclosure, are described in detail below with reference to theaccompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

In addition to the features mentioned above, other aspects of thepresent invention will be readily apparent from the followingdescriptions of the drawings and exemplary embodiments, wherein likereference numerals across the several views refer to identical orequivalent features, and wherein:

FIG. 1A is a simplified illustration of a DNA helix;

FIG. 1B is a simplified illustration of a DNA sequencing test result;

FIG. 2 is a simplified perspective view of an exemplary genetic materialgathering device and an exemplary sequencing device;

FIG. 3 is a simplified perspective view of an exemplary genetic testingdevice for use with the sequencing device of FIG. 2;

FIG. 4A is a simplified plan view of an exemplary system for providinggenetic efficacy testing results, including the sequencing device ofFIG. 2;

FIG. 4B is a flow chart with exemplary logic for distributing the testresults;

FIG. 5A is a flow chart illustrating exemplary logic for identifying,ordering, and performing tests;

FIG. 5B is a flow chart illustrating other exemplary logic foridentifying and ordering tests;

FIG. 6A is a flow chart illustrating exemplary logic for performinggenetic efficacy testing and analyzing results;

FIG. 6B is a flow chart illustrating exemplary logic for integratinggenetic efficacy test results within existing systems;

FIG. 7 is an exemplary healthcare provider interface;

FIG. 8 is a simplified block diagram illustrating exemplary logic foranalyzing genetic efficacy test results and generating alerts;

FIG. 9 is an exemplary laboratory-based prior authorization system inaccordance with the present invention;

FIG. 10 in a flowchart with exemplary logic for operating the system ofFIG. 9;

FIG. 11 is an exemplary pharmacy notification system in accordance withthe present invention;

FIG. 12 is a flowchart with exemplary logic for operating the system ofFIG. 11;

FIG. 13 is another exemplary pharmacy notification system and flow chartin accordance with the present invention;

FIG. 14 is an exemplary enhanced patient update system in accordancewith the present invention;

FIG. 15A is a plan view of an exemplary automated prior authorizationsystem for genetic efficacy testing with prescription dispensation inaccordance with the present invention;

FIG. 15B is a plan view of another exemplary embodiment of the system ofFIG. 15A;

FIG. 16A is a flowchart with exemplary logic for operating the systemsof FIGS. 15A-15B; and

FIG. 16B is a continuation of the flowchart of FIG. 16A.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENT(S)

Various embodiments of the present invention will now be described indetail with reference to the accompanying drawings. In the followingdescription, specific details such as detailed configuration andcomponents are merely provided to assist the overall understanding ofthese embodiments of the present invention. Therefore, it should beapparent to those skilled in the art that various changes andmodifications of the embodiments described herein can be made withoutdeparting from the scope and spirit of the present invention. Inaddition, descriptions of well-known functions and constructions areomitted for clarity and conciseness.

FIG. 1A is a simplified illustration of a DNA helix 4. DNA, ordeoxyribonucleic acid, is a double-helix shaped chain of nucleotidesthat carry the genetic instructions used in the growth, development,functioning, and reproduction of all known living organisms. There arefour major types of nucleobases in any nucleotide of a DNA sequence,which are generally coded as A, T, C, and G for adenine, thymine,cytosine, and guanine, respectively. Each individual human is believedto have a unique DNA structure that defines the persons' genetic makeup.

FIG. 1B is a simplified illustration of a DNA sequencing test result 6.

Upon sequencing of the DNA 4, the presence or non-presence of particularnucleobases (A, T, C, or G) may be detected. The presence andnon-presence or order of such nucleobases can be used to determine thepresence or non-presence of certain genetic markers. The genetic markersmay indicate the existence or non-existence of certain genetic traitsfor the person.

FIG. 2 is a simplified perspective view of an exemplary genetic materialgathering device 10 and an exemplary genetic sequencing device 20. Thegenetic material gathering device 10 may comprise a swab, syringe, vial,strip, or the like. For example, without limitation, the geneticmaterial gathering device 10 may comprise a swab configured to be usedon the inside of the user's cheek to gather saliva and/or skin cells. Inother examples, without limitation, the genetic material gatheringdevice 10 may comprise a syringe configured to gather blood, a vialconfigured to store blood, hair, skin samples, or the like, somecombination thereof, or the like. Any type of genetic material gatheringdevice 10 for gathering any type of genetic material is contemplated.

The genetic sequencing device 20 may comprise any kind of deviceconfigured to sequence genetic material. In exemplary embodiments, thegenetic sequencing device 20 may comprise a loading area 22 and acontrol panel 24. The loading area 22 may be configured to accept one ormore testing devices 30. The control panel 24 may be integrally formedwith the genetic sequencing device 20 or may be a separate electronicdevice in communication with the genetic sequencing device 20. Thecontrol panel 24 may be configured to accept user input comprisinginstructions for carrying out various genetic tests on the testingdevice 30. The control panel 24 may be configured to display the resultsof such testing. Such instructions may, alternatively or additionally,be accepted from a remote device, which may comprise the control panel24 or another device. Testing results may be transmitted to one or moreremote devices and/or systems as further described herein.

FIG. 3 is a simplified perspective view of an exemplary genetic testingdevice 30 for use with the sequencing device 20. In exemplaryembodiments, the testing device 30 may comprise a chip 31 comprised of anumber of wells 32, though any type of testing device 30 iscontemplated. Each of said wells 32 may be configured to test for aparticular genetic marker. The testing device 30 may be configured toaccommodate any number of wells 32. In exemplary embodiments, certainwells 32 may be added or removed from the testing device 30 in order totest for the presence or non-presence of various genetic markers. Forexample, without limitation, wells 32 may be added to the chip 31 totest for particular genetic traits and wells 32 may be removed from thechip 31 if a particular genetic trait is not being tested for. In stillother exemplary embodiments, the wells 32 being used may be placed in anunblocked position such that genetic material may enter the well 32.Similarly, the wells 32 not being used may be placed in a blockedposition such that genetic material may not enter the wells 32.Modifications to the testing device 30 may be performed manually orautomatically based on the instructions for testing received. Forexample, without limitation, the testing device 30 may be constructed ormodified by one or more robots. The testing device 30 may furthercomprise one or more areas 33 to affix labels, markers, or the like, andmay comprise, for example without limitation, unique identifiers,barcodes, QR codes, some combination thereof, or the like.

FIG. 4A is a simplified plan view of an exemplary system for providinggenetic efficacy testing results. The genetic sequencing device 20 maybe in electronic communication with a laboratory system 40. Thelaboratory system 40 may receive testing instructions which arecommunicated to one or more genetic sequencing devices 20. Thelaboratory system 40 may also be configured to receive the results ofany performed tests from the one or more genetic sequencing devices 20.More than one laboratory system 40 may be provided, each of which may bein communication with one or more genetic sequencing devices 20. Inexemplary embodiments, the laboratory system 40 may be a laboratoryfacing system, such as but not limited to a laboratory informationsystem (“LIS”). The laboratory system 40 may be in electroniccommunication with one or more healthcare provider systems 50. Each ofthe healthcare provider systems 50 may comprise patient information, alist of ordered tests, and test results, among other data. Thehealthcare provider systems 50 may communicate instructions for geneticefficacy tests to be performed to the laboratory system 40. The resultsof such ordered genetic efficacy tests may be transmitted from thelaboratory system 40 to one or more of the healthcare provider systems50. In exemplary embodiments, the healthcare provider systems 50 may behealthcare provider facing system such as, but not limited to, anelectronic medical record (“EMR”) system, electronic health record(“EHR”), some combination thereof, or the like. Although someembodiments are discussed with respect to a certain number of geneticsequencing devices 20, laboratory systems 40, and healthcare providersystems 50, any number of such components are contemplated.

The sequencing device 20, the laboratory system 40, and the healthcareprovider system 50 may be located in the same facility, or may be remotefrom one another. The electronic communication may be by way of a wiredor a wireless connection. The electronic communication may further bemade by way of one or more network interface devices and one or morecommunication networks located at each of the sequencing device 20, thelaboratory system 40, and the healthcare provider system 50. Thecommunications networks utilized may include, but are not limited to,the internet, intranet, cellular network, or the like. In exemplaryembodiments, communications between the genetic sequencing device 20,the laboratory system 40, and/or the healthcare provider system 50 maybe made secured and encrypted. Alternatively, or additionally, suchcommunications may be made in a standardized format such as, but notlimited to, a HL7 format. In exemplary embodiments, the genetic efficacytest results may be pulled from the laboratory system 40 such as, butnot limited, to by the use of scanning and archiving software. Thetesting results may be automatically integrated into the healthcareprovider system 50. Such integration may be performed by way of a flatfile, though any method of integration is contemplated. For example,without limitation, the testing results may be automatically integratedinto the EHR utilized by the healthcare provider, preferably as furtherdescribed herein.

Alternatively, or in addition, the test results may be made available tothe healthcare provider by way of an internet-based portal accessedthrough the healthcare provider system 50 or any number of personalelectronic devices 51 in electronic communication with, or constituting,the healthcare provider system 50. In particular, a hyperlink to theportal may be provided to the healthcare provider system 50 such that itis stored as a quick link access, though such is not required. As yetanother example, without limitation, the testing results may be providedto the healthcare provider by way of email to the healthcare providersystem 50. In other embodiments, the testing results may be madeavailable to the healthcare provider by way of an application installedon the various personal electronic devices 51.

The test results stored on the laboratory system 40 may be secured suchthat a particular healthcare provider can only access the results forusers associated with the particular healthcare provider. For example,without limitation, permission may be set such that login credentialsassociated with a given healthcare provider may be permit access to testresults for particular users associated with that healthcare provider.The laboratory system 40 may be configured to periodically downloadtesting results from the genetic sequencing device 20. Similarly, thelaboratory system 40 may be configured to periodically download testingresults to the healthcare providers system 50. Alternatively, or inaddition, certain results may be downloaded on demand. Access to thetesting data, including but not limited to testing results, may beprotected by way of security protocols, such as, but not limited to,authentication, biometric scanning, single sign-on, barcode scanningprotocols, some combination thereof, or the like. The automation andreduction in human interaction provided by the disclosed systems andmethod may reduce the number of potential intrusion points and improvedata security.

Each of the sequencing devices 20, the laboratory systems 40, and thehealthcare provider systems 50 may comprise one or more electroniccomponents. Such electronic components may include, but are not limitedto, processors, electronic storage devices, user input devices,displays, and the like. Each of the sequencing devices 20, thelaboratory systems 40, and the healthcare provider systems 50 maycomprise software instructions configured to perform the steps andfunctions described herein.

FIG. 4B is a flow chart with exemplary logic for distributing thegenetic efficacy test results. In exemplary embodiments, test resultsmay be received from the laboratory system 40 at a health careinformation exchange (“HIE”) 55. The HIE 55 may be in electroniccommunication with a number of healthcare provider systems 50. Each ofthe healthcare provider systems 50 may be in electronic communicationwith one or more personal electronic devices 51. The HIE 55 may beconfigured to automatically distribute the test results to eachhealthcare provider system 50 associated with a healthcare providerknown to be treating the patient. In other exemplary embodiments, theHIE 55 may make the testing results available for integration into anyof the linked healthcare provider systems 50.

In exemplary embodiments, the necessary integration of the laboratorysystem 40 and/or genetic efficacy test results may be performed onlywith respect to a single HIE 55 to permit integration with a number oflinked healthcare provider systems 50. This also may permit informationfor specific data, such as but not limited to unusual cases, to beshared across healthcare providers who may be geographically remote fromone another and/or associated with different practices such that themost relevant information may be made available to healthcare decisionmakers. For example, without limitation, the efficacy data for a patientseen with a relatively rare genetic makeup in Connecticut may be sent toa doctor in Oregon who has a different patient with a similar geneticmakeup.

FIG. 5A is a flow chart illustrating exemplary logic for identifying,ordering, and performing genetic efficacy tests. A user may visit one ormore healthcare providers and present with a variety of symptoms. As thehealthcare provider evaluates the user, including by taking a medicalhistory, evaluating symptoms, and performing tests, the healthcareprovider may enter information about the user into the healthcareproviders' system 50. Already existing information about the user mayalready be present on the healthcare providers' system 50, though suchis not required. Such information already existing or entered by thehealthcare provider might include, for example but without limitation,identification information, demographic information, insuranceinformation, medical history, known allergies, family history, somecombination thereof, and the like. In exemplary embodiments, thehealthcare provider system 50 comprises an EMR and/or an EHR. Theentered information by the healthcare provider at a given visit mayinclude, for example but without limitation, treatment actions taken orprescribed, symptoms presented, diagnosed diseases or conditions, testsordered, testing results, some combination thereof, and the like. Inexemplary embodiments, at least the treatment actions taken orprescribed and the diseases or conditions diagnosed may be enteredand/or converted into codes, such as but not limited to, ICD codes,though any type, protocol, or format of coding is contemplated.

In exemplary embodiments, certain information about the patient may beretrieved by the laboratory system 40 from the healthcare providersystem 50 such as, but not limited, to by the use of scanning andarchiving software. The laboratory system 40 may review the enteredinformation and identify conditions diagnosed, or likely to bediagnosed, treatments prescribed, or likely to be prescribed, to thepatient. The treatments likely to be prescribed, such as but not limitedto medications, may be determined by comparing the entered informationwith standard treatment procedures. Such standard treatment proceduresmay be stored at the laboratory system 40, or at one or more separatedatabases, and may be sourced from public and private data sources. Forexample, without limitation, if a stent placement is ordered for thepatient, the laboratory system 40 may determine that post-operativeblood thinners are likely to be prescribed. The conditions likely to bediagnosed may be determined by comparing the entered information, suchas symptoms and test results, with diseases associated with suchinformation. Such disease information may be stored on the laboratorysystem 40, or one or more separate database, and may be sourced frompublic and private data sources. For example, without limitation, ifchest pain is reported, a likely condition of heart disease may bedetermined.

The laboratory system 40 may identify one or more genetic markers thatmay have a bearing on the effectiveness of prescribed, or likely to beprescribed, treatments. The laboratory system 40 may determine whethertesting for the identified genetic markers fits one or more billingparameters. For example, without limitation, the laboratory system 40may determine whether such testing would be considered medicallynecessary under Medicare regulations and/or guidelines. An exemplarylisting of medically necessary codes is provided in tables 1-2 below.The provided tables are merely exemplary and are not intended to belimiting.

TABLE 1 Cardiovascular Diagnostic Codes Code Description 120.0 Unstableangina 120.1 Angina pectoris with documented spasm 120.8 Other forms ofangina pectoris 120.9 Angina pectoris, unspecified 121.09 ST elevation(STEMI) myocardial infarction involving other coronary artery ofanterior wall 121.11 ST elevation (STEMI) myocardial infarctioninvolving right coronary artery 121.19 ST elevation (STEMI) myocardialinfarction involving other coronary artery 121.29 ST elevation (STEMI)myocardial infarction involving other sites 121.3 ST elevation (STEMI)myocardial infarction of unspecified site 121.4 Non-ST elevation(NSTEMI) myocardial infarction 124.0 Acute coronary thrombosis notresulting in myocardial infarction 124.1 Dressler's syndrome 124.8 Otherforms of acute ischemic heart disease 124.9 Acute ischemic heartdisease, unspecified 125.110 Atherosclerotic heart disease of nativecoronary artery with unstable angina pectoris 125.700 Atherosclerosis ofcoronary artery bypass graft(s), un- specified, with unstable anginapectoris 125.710 Atherosclerosis of autologous vein coronary arterybypass graft(s) with unstable angina 125.720 Atherosclerosis ofautologous artery coronary artery bypass graft(s) with unstable anginapectoris 125.730 Atherosclerosis of nonautologous biological coronaryartery bypass graft(s) with unstable angina pectoris 125.750Atherosclerosis of native coronary artery of transplanted heart withunstable angina 125.760 Atherosclerosis of bypass graft of coronaryartery of transplanted heart with unstable angina 125.790Atherosclerosis of other coronary artery bypass graft(s) with unstableangina pectoris

TABLE 2 Psychiatric and Pain Management Diagnostic Codes CodeDescription F31.30 Bipolar disorder, current episode depressed, mild ormoderate severity, unspecified F31.31 Bipolar disorder, current episodedepressed, mild F31.32 Bipolar disorder, current episode depressed,moderate F31.4 Bipolar disorder, current episode depressed, severe,without psychotic features F31.5 Bipolar disorder, current episodedepressed, severe, with psychotic features F31.60 Bipolar disorder,current episode mixed, unspecified F31.61 Bipolar disorder, currentepisode mixed, mild F31.62 Bipolar disorder, current episode mixed,moderate F31.63 Bipolar disorder, current episode mixed, severe, withoutpsychotic features F31.64 Bipolar disorder, current episode mixed,severe, with psychotic features F31.75 Bipolar disorder, in partialremission, most recent episode depressed F31.76 Bipolar disorder, infull remission, most recent episode depressed F31.77 Bipolar disorder,in partial remission, most recent episode mixed F31.78 Bipolar disorder,in full remission, most recent episode mixed F31.9 Bipolar disorder,unspecified F32.9 Major depressive disorder, single episode, unspecifiedF33.0 Major depressive disorder, recurrent, mild F33.1 Major depressivedisorder, recurrent, moderate F33.2 Major depressive disorder, recurrentsevere without psychotic features F33.3 Major depressive disorder,recurrent, severe with psychotic symptoms F33.40 Major depressivedisorder, recurrent, in remission, unspecified F33.41 Major depressivedisorder, recurrent, in partial remission F33.42 Major depressivedisorder, recurrent, in full remission F33.9 Major depressive disorder,recurrent, unspecified G10 Huntington's disease

In exemplary embodiments, if any of the diagnostic codes provided by thehealthcare provider system 50 fit the provided billing parameters, thenthe genetic testing may automatically be included in the plan oftreatment for that patient.

Alternatively, or additionally, the laboratory system 40 may beconfigured to gather and review insurance information for coverageeligibility for particular types of testing. The laboratory system 40may be configured to determine whether such testing would be wholly orpartially covered by the user's insurance. This may be performed byreviewing the billing codes against those codes covered by the user'sinsurance. This may alternatively or additionally be performed byinterfacing with the user's insurance provider. Regardless, in suchembodiments, the billing parameters may comprise the testing known orlikely to be approved. These billing parameters may be predetermined andpreprogramed and may be selected based on the user's insurance coverage.

Alternatively, or in addition, the laboratory system 40 may beconfigured to generate one or more forms for gathering and authorizingpayment information for desired testing. For example, withoutlimitation, the laboratory system 40, or a separate payment system, maybe configured to store and authorize credit card transactions to pay forthe ordered testing. This option may be provided to, for example withoutlimitation, users who do not have insurance or elect not to billinsurance for such testing. This option may also be provided to coverany co-payment, patient responsible portions, some combination thereof,or the like. In such cases, the billing parameters may be any testingelected by the user. The generated forms may be electronic in nature andmay be generated by the laboratory system 40 for display to the user andreturn to the laboratory system 40 for storage, though such is notrequired.

If the test fits the billing parameters, an option to order testing maybe presented to the healthcare provider at the healthcare providersystem 50. If not, then the test for the next genetic marker may beconsidered. Alternatively, or additionally, if the test fits the billingparameters, it may be automatically added to a list of ordered tests.The presentment of options to order testing may be controlled by thelaboratory system 40, though such is not required.

If the healthcare provider orders the test, or the test is automaticallyadded, the appropriate wells 32 may be added to, or removed from, thetesting device 30 to test for the specified genetic markers.Alternatively, or in addition, the appropriate wells 32 may be blockedor unblocked on the testing device 30 to test for the specified geneticmarkers. Once all identified tests are considered, instructions forassembly of the testing device 30 may be transmitted and the testing maybe performed.

In exemplary embodiments, user information may be gathered, orpresented, using one or more secured means. For example, withoutlimitation, information may be gathered and entered into the personalelectronic devices 51 running a secured browser application. Thepersonal electronic devices 51 may comprise remote shut downcapabilities and a variety of security protocols, such as but notlimited to, authentication, biometric scanning, single sign-on, barcodescanning protocols, some combination thereof, or the like may beutilized.

Other information gathered from the user may include scanned copies ofinsurance card and photo ID. Forms such as digital consent forms,educational information, questionnaires, and medical necessity forms maybe digitally filled out, stored, and/or transmitted. The laboratorysystem 40 and/or the healthcare provider system 50 may be configured togenerate a QR code, barcode, label, or other identifier for attachmentto the genetic material gathering device 10, the genetic testing device,paperwork, some combination thereof, or the like. Scanning of the QRcode, barcode, label, or another identifier may automatically retrievethe associated user information.

FIG. 5B is a flow chart illustrating other exemplary logic foridentifying and ordering tests. Diagnostic and/or procedure codes may beentered by the healthcare provider. Preferably, such diagnostic and/orprocedures codes are entered at the respective personal electronicdevice 51 for the respective healthcare provider system 50. Thediagnostic and/or procedure codes may conform to InternationalClassification of Diseases (“ICD”), though any type, standard, protocol,etc. of coding is contemplated. If the diagnostic and/or procedure codesmeet medically necessary criteria for a given genetic efficacy test, forexample without limitation, then the test may be automatically added toa list of ordered tests to be transmitted to the laboratory system 40.If the diagnostic and/or procedure codes fail to meet medicallynecessary criteria, for example without limitation, then the next testmay be considered until all possible tests are exhausted.

Once all tests are considered, the list of order tests may betransmitted to the laboratory system 40. The diagnostic and/or procedurecodes may be utilized to determine which genetic efficacy tests arerelevant. In other exemplary embodiments, a list of particular genetictests may be considered for each patient. The medically necessarycriteria may be under Medicare and/or Medicaid guidelines, though anyprotocol, standard, or the like is contemplated. Other criteria arecontemplated in addition to, or as an alternative to, the medicallynecessary criteria.

In this way, eligible test results may be automatically added to anorder. Being a cutting-edge field, genomic efficacy testing is sometimesunknown or under considered by healthcare providers. The disclosedsystems and methods not only permit the determination of insuranceeligibility for such testing, but may automatically add such eligibletests to help ensure that a patient receives the highest quality of careand maximizes the information available to healthcare providers.

FIG. 6A is a flow chart illustrating exemplary logic for performinggenetic efficacy testing and analyzing results. Genetic material fromthe user may be gathered by way of the genetic material gathering device10. A genetic testing device 30 comprising wells 32 for the orderedtesting may be assembled. Such assembly may be performed manually orautomatically. Such assembly may be performed concurrently, before, orafter obtaining the genetic material. The genetic material may then besequenced using the genetic sequencing device 20.

The testing may determine the presence or non-presence of the geneticmarkers for which the testing is performed. The results of such testingmay be transmitted to the laboratory system 40. The results may becompared against information stored in the laboratory system 40, orelsewhere, regarding the effectiveness of given treatment options, suchas but not limited to medications, in persons having or not havingparticular genetic markers. In particular, the results may be comparedfor each of the treatments prescribed to the user, or likely to beprescribed to the user. Similarly, the results may be compared againstinformation stored in the laboratory system 40, or elsewhere, regardingthe need for particular dosages or treatments in persons having or nothaving particular genetic markers. In particular, the results may becompared for each of the treatments and/or dosages prescribed to theuser, or likely to be prescribed to the user. Such information may begathered from one or more public or private sources such as, but notlimited to, the human genome project. In exemplary embodiments, thelaboratory system 40, the healthcare provider system 50, and/or anothersystem may be configured to prompt the healthcare provider to perform afollow-up telephone call regarding the test results a period of timeafter electronically transmitting the results to the patient.

The laboratory system 40 may be configured to flag ineffectivetreatments and/or dosages. Likewise, the laboratory system 40 may beconfigured to flag effective treatments and/or dosages. In exemplaryembodiments, the results may be color coded. For example, withoutlimitation, red color coding may indicate an ineffective treatmentand/or dosage. A yellow color coding may indicate the need to adjust thetreatment and/or dosage or monitor use of the therapy. A green colorcoding may indicate that the treatment and/or dosage is acceptable.Other colors and types of coding are contemplated.

The results of the testing may be transmitted to the healthcare providersystem 50. The laboratory system 40 may be configured to automaticallysuggest alternative medications, or dosages, or treatment options forthose treatments flagged to be ineffective or requiring adjustments.Furthermore, the healthcare provider system 50 may be updated to reflectthe ineffectiveness of the treatments and/or dosages. For example,without limitation, ineffective treatments may be flagged or otherwisecoded as an allergy in the user's file. More specifically, ineffectivetreatments may be identified in the message to the healthcare provider.For example, without limitation, this information may be added to theHL7 electronic results, such as but not limited to the PathX HL6electronic communication, that are received with the test results andembedded into any .pdf type files generated from the HL7 file.

Alternatively, or in addition, additional parties may be notified oftreatments and/or dosages determined to be ineffective. Such parties mayinclude, but are not limited to, pharmacists, project managers,healthcare practice administrators, insurance providers, users, otherhealthcare providers, other approved persons, and the like. The resultsof the testing may be transmitted to each parties' respective system 50.

One or more healthcare information exchanges (“HIEs”) may be utilized toprovide information between various systems 50 and individuals. Forexample, without limitation, the results of the testing mayautomatically be shared with the healthcare provider system 50 for eachhealthcare provider treating the user. Each healthcare provider treatingthe user may automatically be granted access to the results of thetesting, such as by way of the respective healthcare provider's personalelectronic device 51. In exemplary embodiments, the HIE 55 may providetwo-way communication such that information may be transmitted to andfrom the laboratory system 40.

FIG. 6B is a flow chart illustrating exemplary logic for integratinggenetic efficacy test results within existing healthcare providersystems 50. Existing healthcare providers system 50, such as but notlimited to EHRs, may not have a dedicated space for the integration ofgenomic testing results. Redesigning existing systems to provide such adedicated space would be time consuming and expensive. As such, inexemplary embodiments, after receiving the genetic efficacy testingresults and determining which treatment options are ineffective and/orhave a reduced efficacy, such treatment options may be designated as anallergy in the user's file. Many, if not all, existing healthcareprovider systems 50 have a designated space for the notation ofallergies. As such, this provides a pathway for integration of genomicefficacy testing results into the patient's electronic file. Helpfully,in many cases, the healthcare provider system 50 is configured to raisean alert or otherwise provide some kind of notification uponprescription of such treatments flagged as an allergy. In this way, forexample without limitation, ineffective medications and/or dosages maybe alerted to the healthcare provider when ordering at the healthcareprovider system 50.

FIG. 7 is an exemplary healthcare provider interface 60. The healthcareprovider interface 60 may be displayed on one or more personalelectronic devices 51 in electronic communication with the healthcareprovider system 50. The personal electronic devices 51 may includecomputers, smartphones, tablets, some combination thereof, or the like.The interface 60 may provide results for one or more patients. Theinterface 60 may alternatively, or in addition, provide the results formultiple medications for a one or more patients. In exemplaryembodiments, the results may be presented with the clinical consequencesof prescribing each of the therapies. For example, without limitation,the interface 60 may inform the healthcare provider of whether theprescribed therapy is likely to be effective, partially effective,wholly ineffective, or the like. The healthcare provider interface 60may be updated for each individual healthcare provider user 62. Thehealthcare provider's recently accessed files may be identified 64. Aquick links section 66 may include a link to the portal for testordering and results. A schedule 68 may include one or more indicators70 which patient(s) have possible warnings associated with their testresults. For example, without limitation, the results may be colorcoded. Such warnings may be provided as a result of coding theineffective treatment options as an allergy in the user's file.

In other exemplary embodiments, indicators 70 may be presented in theform of alerts. Such alerts may include pop-ups, warning signals,electronic messages, some combination thereof, or the like. Suchindicators 70 may be generated upon the receipt of results whichindicate that the healthcare provider has prescribed a treatment, suchas but not limited to a drug, to a patient known to be a non-responderto such treatments, the presence of abnormal result or range, theprescription of a treatment known to cause an allergic effect in thepatient, or the prescription of a treatment which may potentially causean interaction with a drug previously prescribed to the patient, or witha disease the patient is diagnosed with as understood in view of theanalyzed genetic information. Other clinical information may betransmitted and displayed on the interface 60 such as, withoutlimitation, an explanation of the results.

FIG. 8 is a simplified block diagram illustrating exemplary logic foranalyzing genetic efficacy test results and generating alerts. Once theresults of the genetic analysis are received, they may be reviewed. Thereview may include a comparison against information known about thepatient, for example, by analyzing the patient's medical records asstored at one or more of the healthcare provider systems 50. Forexample, without limitation, the results may be reviewed to determine ifthe healthcare provider has prescribed, or is likely to prescribe, atreatment, such as but not limited to a drug, to a patient known to be anon-responder to such treatments, if the results include an abnormalresult or range, if the healthcare provider has prescribed a treatmentknown to cause an allergic effect in the patient, and/or if thehealthcare provider has prescribed a treatment which may potentiallycause an interaction in view of the analyzed genetic information. Theclinical information required to support this analysis may be retrievedfrom one or more databases, such as but not limited to, the healthcareprovider system 50 or a database comprising various known medicalinformation such as known drug interactions based on genetic makeup,normal results or ranges for various medical tests, and the like. Theresults of this review may be used to code the results displayed at theinterface 60 or generate alerts as appropriate.

The comparison, analysis, and the like described herein may be performedat the laboratory system 40 or at the healthcare provider system 50. Itis contemplated that any type of clinical information may be transmittedfor display at the interface 60. The genetic information and testresults may be stored at the laboratory system 40, the healthcareprovider system 50, and/or another system to also be used against futureprescribed treatments. In this way, the testing results may stay withthe patient such that they can be referred to in the future as aperson's genetic makeup generally remains unchanged throughout theirlife.

The clinical consequence of prescription, in exemplary embodiments, maybe added to the electronic results and embedded into a single file fortransmission to the healthcare provider system 50, though multiple filesmay be utilized. This may remove the need for use of multiple file typesbetween the laboratory system 40, the healthcare provider system 50, andthe electronic displays or individual systems 51. This mayalternatively, or in addition, remove the need for multiple file typesto be transmitted to one of the aforementioned systems. For example, onefile with the results and another file with any alerts or other clinicalinformation, though such an embodiment is contemplated. In exemplaryembodiments, the results and all other related clinical information maybe transmitted in a single standardized file, such an HL7 type file,though any file type is contemplated. This may permit the report to beintegrated into any EHR system. In other exemplary embodiments, suchclinical consequences may be transmitted by designating the particulartreatment options likely to be ineffective or undereffective as anallergy. In exemplary embodiments, the genetic information and/or testresults may be temporarily stored at the laboratory system 40 and/oranother electronic storage device such that the data may be reformattedor otherwise modified as required to integrate with the HIE 55 and/orthe various healthcare provider systems 50.

The coding and alerts described herein may be individualized based onthe preferences of each user or entity. For example, when communicatingresults to a first healthcare provider system 50, alerts may begenerated only when certain predetermined conditions are met. Likewise,when communicating results to a second healthcare provider system 50alerts may be generated only when other predetermined conditions are metwhich may be the same or different from (with some overlap, completeoverlap, or no overlap) with the predetermined conditions used togenerate alerts for communications to the first healthcare providersystem 50. Similarly, preferences may be altered for each personalelectronic device 51.

In exemplary embodiments, the results may be transmitted along witheducational information regarding the genetic testing results, a spacefor progress notes, and order information. In exemplary embodiments, thelaboratory system 40, the healthcare provider system 50, or anothersystem, may automatically schedule a follow up telephone encounter forapproximately 1 week after the results are transmitted or the order isplaced for testing.

FIG. 9 illustrates an exemplary laboratory based prior authorizationsystem 100. FIG. 10 illustrates exemplary logic for operating the system100. The system 100 may comprise one or more healthcare provider officesystems 102. The healthcare provider office system 102 may comprise oneor more EHR systems 104, though the use of EMRs is also contemplated.While illustrated as part of the healthcare provider system 102, the EHR104 may be separate from, and in electronic communication with, thehealthcare provider office system 102. The healthcare provider officesystem 102 may comprise, alternatively or additionally, one or moretelephones, fax machines, personal electronic devices, displays,databases, servers, some combination thereof, or the like. The EHRsystem 104 may comprise health information regarding one or morepatients. The EHR system 104 may comprise medications, diagnoses,insurance information, identifying information, medical historyinformation, billing information, contact information, some combinationthereof, or the like.

The healthcare provider office system 102 may be in electroniccommunication with a laboratory system 106. The laboratory system 106may comprise a Laboratory Information System (“LIS”) 108. The laboratorysystem 106 may comprise, alternatively or additionally, one or moretelephones, fax machines, personal electronic devices, displays,databases, servers, some combination thereof, or the like. Thelaboratory system 106 may comprise one or more genetic sequencingdevices 120. The genetic sequencing devices 120 may each be inelectronic communication with the LIS 108. The genetic sequencingdevices 120 may each be the same or similar to genetic sequencingdevices 20 shown and described with respect to FIG. 2. The geneticsequencing devices 120 may each comprise a controller, which may includethe same or similar to the control panel 24 shown and described withrespect to FIG. 2, though such is not required.

Order information may be transmitted from the healthcare provider officesystem 102 to the laboratory system 106. The order may be transmitted inelectronic form. In exemplary embodiments, the order may comprise an HL7order. The order may be transmitted from the EHR 104 to the LIS 108,though such is not required. A specimen for the order may be transmittedfrom the healthcare provider office system 102 to the laboratory system106. The specimen may comprise the genetic material gathering device 10,which may comprise genetic material for testing. In other exemplaryembodiments, optical recognition software may be utilized to recognizeand input order information.

It is notable that any number of healthcare provider offices 102 may beutilized and be in electronic communication with the laboratory system106. Each healthcare provider office system 102 may have its own EHRsystem 104 or may share EHR systems 104 with other healthcare provideroffice systems 102.

The order may be transmitted electronically. The laboratory system 106may receive the order and automatically parse the data to generate oneor more prior authorization requests. In exemplary embodiments, theorder may be transmitted from the EHR 104 and/or received at the LIS108, which may be configured to perform the electronic parsing and priorauthorization request generation. In exemplary embodiments, theelectronic parsing and prior authorization request generation may beperformed by an automated pre-approval request engine 109. The parseddata may comprise, for example without limitation, identificationinformation, demographic information, insurance information, orderinformation, diagnosis information, current procedural terminology (CPT)information, active medications for the patient, some combinationthereof, or the like. At least some of this information may,alternatively or additionally, be obtained by electronic query of theEHR system 104. Retrieval from the EHR system 104 may ensure that themost updated information is being utilized. Updated information may beautomatically utilized without the need to send a redundant update tothe LIS 108 as such updated information may be automatically retrievedand integrated.

In exemplary embodiments, the active medication and/or diagnosisinformation may be obtained from the EHR 104 and may facilitate theability for the payor or prior authorization provider 110 to determinethe medical necessity of the ordered testing. The prior authorizationrequest may comprise the data parsed from the incoming genetic testsorder and/or information retrieved from the EHR 104. The LIS 108 may beconfigured to retrieve such data and generate a prior authorizationrequest formatted in the fashion desired by the payor or priorauthorization provider 110. In this way, the laboratory system 106 maybe positioned to automatically obtain prior authorization withoutadditional involvement of the healthcare provider office system 102.This may prevent the duplication of data at both the healthcare provideroffice system 102 and the laboratory system 106. In exemplaryembodiments, such information may be retrieved, parsed, formatted, andtransmitted by the automated pre-approval request engine 109, thoughsuch is not required.

In exemplary embodiments, the LIS 108 may be configured to generate andsubmit a prior authorization request before an order is submitted. Forexample, without limitation, the LIS 108 may be prompted by thehealthcare provider office system 102 to review a specific patient filefor eligible genetic tests. As another example, without limitation, theLIS 108 may be configured to review new entries made at the EHR 104 foreligible genetic tests. In such cases, the same or substantially thesame, systems and methods may be utilized to obtain prior authorizationand generate a list of eligible tests in the form of a proposed orderwhich is transmitted to the healthcare provider office system 102 forapproval. The EHR 104 may be configured to display the proposed orderfor affirmation by the healthcare provider. In other exemplaryembodiments, the proposed order may be automatically placed.

The parsed information may be automatically transformed into one or moreprior authorization requests. The prior authorization request(s) may betransmitted from the laboratory system 106 to the payor or priorauthorization provider 110. The payor or prior authorization provider110 may process the prior authorization request(s) and return areference identifier and/or patient responsibility amount to thelaboratory system 106.

For example, without limitation, the patient responsibility may comprisea monetary amount due, a copayment, a deductible, coinsurance, a denialof coverage, an approval of coverage, a percentage of costs due, anegotiated price, an amount covered, some combination thereof, or thelike. The reference identifier may comprise a number, code, or otherunique identifier.

The patient responsibility may be determined by applying one or morepolicy rules. The policy rules may be stored at a database. The policyrules may comprise eligibility determinations based on the orderedtests, diagnostic codes, treatment codes, some combination thereof, orthe like. The policy rules, additionally or alternatively, may comprisemedically necessary criteria. The policy rules may comprise patientresponsibility rules, such as not but not limited to, co-pays,coinsurance, deductibles, negotiated rates, some combination thereof, orthe like. The policy rules may be specific to various policies providedby the payor. The payor or prior authorization provider 110 may beconfigured to retrieve the policy rules based on the patient informationand/or insurance information received and apply the policy rules to theordered tests to determine eligibility and patient responsibility.

Where the patient responsibility is below a predetermined threshold, theLIS 108 may be configured to transmit instructions to the geneticsequencing device 120 to initiate the ordered testing. Upon completion,the results may be returned from the genetic sequencing device 120 tothe LIS 108. The LIS 108 may be configured to transmit the results, suchas but not limited to, in notification, instruction, and/or report form,to the EHR system 104. For example, without limitation, thepredetermined threshold may be $50 USD. Any amount may be utilized forthe predetermined threshold. Where the patient responsibility is abovethe predetermined threshold, a call center notice may be automaticallygenerated by the laboratory system 106 and transmitted to a call centersystem 112. The call center notice may be transmitted from the automatedpre-approval request engine 109, in exemplary embodiments. In exemplaryembodiments, the automated pre-approval request engine 109 and/or theLIS 108 may be in direct electronic communication with the payor orprior authorization provider 110.

The call center notice may comprise information from the parsed dataand/or returned from the payor or prior authorization provider 110. Suchinformation may be communicated to the automated pre-approval requestengine 109, in exemplary embodiments. In exemplary embodiments, anelectronic notification may be automatically generated with call centernotices for all claims received from the payor or prior authorizationprovider 110 in a given period of time. The electronic notification maybe transmitted to the call center system 112. The call center system 112may be provided at the laboratory 106 or may be remote therefrom. Forexample, without limitation, an encrypted email may be automaticallygenerated periodically with attached call center notices for all claimsprocessed by the payor or prior authorization provider 110 in a periodof time, such as but not limited to the prior 1-24 hours. Any timeperiod is contemplated such as, but not limited to, 4 hours, 12 hours,24 hours, some combination thereof, or the like. In this way, one maysimply check to see that the electronic notifications are beingperiodically transmitted to verify that the system is functioningproperly. This may result in consistent, faster data processing.

The call center system 112 may be configured to contact the patient 116and inform the patient 116 of the patient responsibility required toproceed. The call center system 112 may comprise one or more automaticdialers, text message generators, email generators, some combinationthereof, or the like. For example, without limitation, the call centersystem 112 may be configured to automatically extract patient contactinformation, such as but not limited to, phone numbers, email addresses,some combination thereof, or the like, and automatically generatemessages and/or dial, text, email, some combination thereof, or the likethe patient to obtain the patient's consent to proceed.

Payment information may be collected and/or processed by a paymentprocessing system 114. The payment processing system 114 may be internalto the call center system 112 or external. The payment informationcollected and/or processed may comprise credit card information, debitcard information, electronic checks, wire information, bank accountinformation, some combination thereof, or the like. The paymentprocessor 114 may be configured to process the payment informationreceived. The payment processing system 114 may return confirmation ofpayment. The funds may be electronically transferred to a financialinstitution 118, such as but not limited to a bank, associated with thelaboratory system 106. In this way, the number of parties having accessto sensitive financial information is reduced. This may prevent the needto transmit funds between multiple institutions. This may reduce thenumber of access points to sensitive financial information, therebyincreasing data security.

Where the patient 116 elects not to proceed with the ordered testing,notification regarding the same may be transmitted from the LIS 108 tothe EHR 104. Such notification may additionally be transmitted from thecall center system 112 to the LIS 108. In exemplary embodiments, where apredetermined number of contact attempts are made from the call centersystem 112 to the patient 116, and no reply is received, the patient 116may be deemed to have not consented. For example, without limitation,the predetermined number of attempts may be three attempts. The callcenter system 112 may be configured to automatically track the number ofattempted contacts. For example, without limitation, an automated dialerat the call center system 112 may be configured to extract andautomatically dial the user three times, if no call is picked up, theuser may be deemed to have not consented. Upon receipt of notificationof denial of consent (whether through explicit denial, lack of abilityto contact patient, or otherwise) the specimen may be destroyed. Forexample, without limitation, the call center system 112 may beconfigured to generate an electronic notification regarding the denialwhich is transmitted to the LIS 108, which in turn generatesinstructions to destroy the specimen.

Upon receipt of notification of consent and/or payment, the LIS 108 maygenerate instructions to the genetic sequencing device 120 to begintesting the specimen. For example, without limitation, the call centersystem 112 may be configured to generate an electronic notificationregarding the consent and/or payment which is transmitted to the LIS108, which in turn generates instructions to proceed with the orderedtesting. The specimen may be analyzed and results regarding the same maybe generated and transmitted to the LIS 108. The LIS 108 may transmitthe results to the healthcare provider office system 102. For example,without limitation, the LIS 108 may integrate the testing results intothe EHR 104. In exemplary embodiments, the testing may comprisemedication efficacy testing and the LIS 108 may be configured to flagineffective medications as allergies at the patient file at the EHR 104.

The LIS 108 may be configured to determine, from the informationobtained from the payor or prior authorization provider 110, any paymentowed by the payor or prior authorization provider 110 and may beconfigured to be automatically generate an invoice with the owned amountand transmit the invoice the payor or prior authorization provider 110with the reference number and other necessary information. The callcenter notices may comprise the reference number for tracking purposes.In exemplary embodiments, the invoice may be generated and transmittedelectronically. In this way, payment may be secured by the laboratorywithout intervention by the healthcare provider office and/or the user.This may reduce the need for duplicate invoicing information whichotherwise would be sent to the healthcare provider and then on to thepayor, thereby reducing burdens on sever use and electronic storage.

The transmissions, receipts, parsing, generation, and the like shownand/or described herein may be accomplished electronically. This mayreduce or eliminate the number of human interactions required. This mayreduce the potential for error and/or speed up data processing. Forexample, without limitation, the system may be configured to achieve anerror rate of less than 1%. This may reduce the need for certainhealthcare provide resources, thereby reducing costs and complexity. Theentire process may be completed while the specimen is in transit to thelaboratory system 106, though such is not required. The specimen, uponarrival, may be associated with the reference number for trackingpurposes. Such association may be made by way of a barcode, QR code,label, identifier, some combination thereof, or the like which may bephysically associated with the specimen.

The LIS 108 may comprise data indicating prior authorization providersassociated with various insurance providers such that the insuranceprovider may be contacted directly, or prior authorization provider maybe contacted when appropriate. Such data may be stored at one or moreremote databases.

The predetermined amount which triggers contacting the patient tocollect payment may be specified in a consent document. The billingconsent document may be provided to the healthcare provider officesystem 102. The billing consent document may be signed at the same timethe specimen is collected, and may inform the patient that they may ormay not receive a call in the next day or so. The consent document maybe provided in electronic form and may be electronically returned to theLIS 108 for recordation. The consent document may be electronicallygenerated by the LIS 108 and electronically transmitted to thehealthcare provider office system 102, such as but not limited to by wayof the EHR 104, for patient 116 signature though such is not required.In other exemplary embodiments, a paper or other copy of the consentdocument may be provided to the patient and may be scanned or otherwiseconverted to electronic form for storage. The consent document may formpart of the proposed or suggested order, though such is not required.

While certain systems, such as but not limited to the call center system112, the payment processing system 114, are illustrated as separate fromthe laboratory system 106, such systems may be integrated with thelaboratory system 106 and may be provided as subsystems of the LIS 108,for example.

FIG. 11 is an exemplary pharmacy notification system 126 in accordancewith the present invention and FIG. 12 is a flowchart with exemplarylogic for operating the pharmacy notification system 126. Patent datamay be received at the LIS 108 from the healthcare provider office 102.Such patient data may include prescribed and/or reported medications.Such patient data may be received from the patent 116 during anappointment and recorded at the EHR 104. The healthcare provider 102 mayorder certain genetic efficacy testing. Such orders may be recorded atthe EHR 104. The patient 116 may also provide authorization for testingand/or give a specimen for testing at the appointment.

The specimen, ordered testing information, and patient data may betransmitted to the laboratory 106 as shown and described herein. Oncethe testing is completed, a report may be transmitted back to thehealthcare provider office 102 and/or integrated into the EHR 104 asshown and described herein.

A notification regarding medications flagged as ineffective based on theordered testing results may be sent to one or more pharmacy benefitsproviders (“PBM”) 122. Such transmission may be alternatively to, or inaddition to, transmission to the healthcare provider office 102 and/ordirect integration with the EHR 104. The PBMs 122 may electronically orotherwise interface with dispensing pharmacies 124 for the patients 116.Interfacing with the PBMs 122 may provide an effective way to reach alarge number of patients 116 as each PBM 122 may manage pharmacybenefits for a larger population of patients 116. While prescriptionorders may be sent directly to the PBM 122, in other exemplaryembodiments, the prescriptions may first be sent to the filling pharmacy124 who may relay them to the PBM 122.

The notification may indicate that one or more medications have beendetermined to be ineffective based on the patient's 116 genetic makeup.The healthcare provider office 102 and/or the pharmacy 124 may relayrequests for coverage approval for certain medications. The PBM 122 maynotify the pharmacy 124 that coverage is denied and/or to not fill oneor more prescriptions where they are indicated as being ineffective inthe testing results received from the LIS 108. In this way, the pharmacy124 may be prevented from filling the prescription(s) and/or the patient116 may be prevented from ever receiving the prescribed medication(s),thus reducing costs.

The notification may indicate that one or more medications have beendetermined to be effective based on the patient's 116 genetic makeup.The PBM 122 may notify the pharmacy 124 to proceed with filling one ormore prescriptions which are indicated as effective in the testingresults (e.g., those not indicated as being ineffective), therebyreducing costs by ensuring only effective medications are filled anddispensed. In other exemplary embodiments, a lack of notification aftera period of time may be treated as an indication that such prescribedmedications are considered effective. The notification may take the formof a claim denial and/or the PBM 122 may be configured to automaticallygenerate a claim denial upon receipt of such a notification. Suchrequests for coverage may be transmitted with, or separately from, thetesting results. Such requests may be transmitted around the same timeas the testing, or much later.

The notifications described herein may be electronic in nature and maybe electronically transmitted between computerized systems located atthe laboratory 106, the PBM 122, and/or the pharmacy 124. Alternatively,or additionally, such notification may be made by phone, email, textmessage, automated call, some combination thereof, or the like.

Where one or more prescriptions are indicated as being ineffective, theLIS 108 may be configured to provide alternative medications, in thenotification or separately, which are effective based on the patient'sgenetic makeup. In such cases, the PBM 122 may notify the pharmacy 124of such alternatives which may be presented to the patient 116 forapproval and/or substituted automatically. The notification may flag theineffective medications as an allergy in the patient's 116 file at thePBM 122 system and/or the pharmacy 124 system. This may permitintegration into existing systems such as but not limited to those whichutilize and/or interface with EHRs 104. This may, alternatively oradditionally, provide automatic notification in the event of futureattempts to prescribe and/or dispense such flagged medications and/ortreatments. The notification may comprise the full report transmitted tothe healthcare provider's office 102, such as for integration into theEHR 104, or may be a different (e.g., simplified, reformatted) version.In other exemplary embodiments, the notification may be sent directlythe pharmacy 124.

Any of the embodiments shown and described herein may be used togetheror separately from one another. For example, without limitation, thelaboratory based prior authorization system 100 may be used separatelyfrom, on in conjunction with, the pharmacy notification system 126. Asyet another example, the interface 60 may be provided at the LIS 108,the EHR 104, the PBM 122, the pharmacy 124, some combination thereof, orthe like.

FIG. 13 illustrates another exemplary system 100 and flow chart foroperating the same in accordance with the present invention. As part ofan identification process 202, the payor 110 may work with thelaboratory 106 to develop a testing contract 210. The testing contract210 may be developed, at least in part, by the payor 110 executing adata algorithm or filter 212 which identifies members 116 of itspopulation which are likely eligible for testing. The data algorithm orfilter 212 may be configured to identify members 116 having knowndiseases or conditions and/or reported to be taking medications orundergoing treatments which may render the member 116 eligible fortesting. Such diseases or conditions and/or medications or treatmentsmay be identified by way of standardized coding, such as but not limitedto IDC 10 codes. E.g., F32.9 Depression ICD10. In this way, the payor110 and/or the laboratory 106 may identify the extent of testing likelyto be needed. The laboratory 106 and payor 110 may negotiate 214 andenter an agreement 210. The agreement 210 may comprise a flat fee, a pertest fee, a subscription model, monthly payments, annual payments, somecombination thereof, or the like.

With the agreement 210 established, an outreach phase 204 may begin. Thecall center 112 may reach out to each patient 116 identified by the dataalgorithm or filter 212. Outreach efforts may include telephonic calls,video calls, automated calls, emails, text messages, letter campaigns,some combination thereof, or the like. The outreach efforts may identifythe payor 110 covered testing available to the patient 116. Suchoutreach efforts may, alternatively or additionally, be made tohealthcare providers 102. The call center 112 representative mayestablish contact, inform the patient 116 of the eligible testing,request and receive consent for testing, and schedule a visit with ahealthcare provider 102 who orders the testing, such as but not limitedto, genetic efficacy testing. Such outreach efforts may be undertaken bythe automated generating and transmission of instructions for the same.

The healthcare provider 102 may be the same or a different from thepatient's 116 normal healthcare providers 102. In exemplary embodiments,the healthcare provider 102 may provide a telemedicine consultation andone or more orders for the lab panel. The orders may be electronicallytransmitted to the laboratory 106.

Upon ordering, the healthcare provider 102 may electronically transmitthe order to a fulfilment center 216. The fulfilment center 216 may shipa kit directly to the patient 116 and/or their pharmacy 124 forgathering the genetic material for testing. The kit may include, forexample without limitation, the genetic material gathering device 10,instructions for collection, a consent form, an invoice, returninstructions, return label, some combination thereof, or the like.

During a collection phase 206, the patient 116 and/or their pharmacy 124may collect the genetic material, such as but not limited to, by way ofthe genetic material gathering device 10 provided in the kit from thefulfilment center 216. The kit and/or the genetic material gatheringdevice 10 may be delivered to the laboratory 106. For example, withoutlimitation, such collection may be done by a self-swab, a drive throughswab, or a face-to-face encounter.

The laboratory 106 may perform the ordered testing. The results may betransmitted to the PBM 122. The PBM 122 may integrate the results byflagging any ineffective or undereffective medications and/or treatmentsas an allergy in the patient file. This may prevent future approval ofsuch medications and/or treatments, and/or may permit integration withexisting systems. The PBM 122 may deny coverage for such ineffective orundereffective medications and/or treatments. Results may also betransmitted to one or more of the healthcare providers 102 and thepharmacy 124.

The PBM 122 may contact the pharmacy 124 regarding approved or deniedprescription medication coverage based on the testing results. Suchcontact may be made by way of electronic notification. The pharmacy 124may contact the patient 116 regarding such results and/or coverageapprovals or denials. Such contact may be made by way of electronicnotification. The testing results may include possible alternativemedications and/or treatments which may likewise by relayed to thepatient 116.

The pharmacy 124 may utilize a tele-pharmacy system 218 to contact thepatient 216 regarding testing, results, coverage approval/denial,alternative medications or treatments, some combination thereof, or thelike.

FIG. 14 illustrates an enhanced patient update system 142. The enhancedpatient update system 142 may be configured to facilitate the update ofmedical information to some or all of the many relevant parties. The LIS108 may be in electronic communication with one or more of: hospice homeproviders 140, PBM 122, payors 110, combinations thereof or the like.This listing is merely exemplary and is not intended to be limiting. Anynumber and/or type of systems for any number and/or type of providers orrelevant third parties may be in electronic communication with the LIS108. The LIS 108 may, alternatively or additionally, be in electroniccommunication with one or more EHR systems 104 for one or morehealthcare providers or other third parties. Such electroniccommunication between the LIS 108 and the EHR systems 104 and/or otherparties shown and/or described herein may be accomplished using one ormore HIEs 55. The HIEs 55 may be in electronic communication with anumber of the relevant third parties (e.g., hospice home providers 140,PBM 122, payors 110, etc.) and/or EHRs 104.

At least some of the third parties, such as but not limited to thehospice home providers 140, may comprise an EHR system 104.

Such electronic connection may be accomplished by way of one or morenetworks including, but not limited to, internets, intranets, cellularnetworks, combinations thereof, or the like. As information istransferred between such entities, it may be converted form a fileformat specific to the system used by the transmitting entity and acommon format for transfer. Such conversion may happen at thetransmitting entities' system, at a common module, a dedicatedappliance, the LIS 108, the HIE 55, combinations thereof, or the like.The commonly formatting information may subsequently be transferred andconverted into a format specific to the receiving entity. Suchconversion may happen at the receiving entities' system, at a commonmodule, a dedicated appliance, the LIS 108, the HIE 55, combinationsthereof, or the like. Regardless, the transferred information may flowthrough the LIS 108 which may act as a hub for the control anddistribution of such information. The LIS 108 may exclusively compriseinformation in the common format, though such is not required. The LIS108 may be configured to build a database of updated patient informationas such information is passed through the LIS 108, such as to othersystems or parties.

While passing through the LIS 108, or at another time, the LIS 108, byitself or in conjunction with other systems, may be configured toperform some or all of the methods shown and/or described herein. Forexample, without limitation, the LIS 108 may be configured to suggestcertain test, such as but not limited to genetic efficacy testing,meeting certain conditions, such as shown and described with respect toat least FIGS. 5A-5B. Alternatively or additionally, the LIS 108 may beconfigured to provide instructions and/or commands for performing suchtesting, such as shown and described with respect to FIGS. 2-4.Alternatively or additionally, the LIS 108 may be configured todesignate, or send commands and/or instructions to so designate, suchineffective medications as an allergy at the patient's electronic fileat the LIS 108, at the various EHRs 104, at other third party systems,combinations thereof, or the like, such as shown and described withrespect to at least FIGS. 4-8. Alternatively or additionally, the LIS108 may be configured to determine and manage eligible testing, suggestalternative treatments and/or stop the fill of ineffective medications,such as shown and described with respect to at least FIGS. 9-13. Theseare merely exemplary and are not intended to be limiting, other examplesof such enhanced updates include, but are not limited to, integratingUTI and STI test results to identify UTI and/or STI antibioticresistance alerts, women's health related information, combinationsthereof, or the like.

The patient update system 142 may provide for faster information updatesacross the third parties and/or EHRs 104 by centralizing the informationflow through the LIS 108 and providing the ability to quickly transferthe information to other such entities.

The patient update system 142 may further provide for precision therapyby suggesting tests which reveal ineffective medications or othertreatments, suggests alternative treatments, stops the payment of and/orfill of ineffective medications, combinations thereof, or the like.

The EHR systems 104 may be associated with any type of healthcareprovider including, but not limited to, primary care providers,specialists, hospitals, clinics, urgent care facilities, hospiceproviders, nursing homes, rehab facilities, testing centers, healthcenters, government facilities, private facilities, combinationsthereof, or the like.

The information transmitted may include any type of kind of informationincluding, but not limited to, patient information, medical information,medication lists, diagnosis, demographic information, insuranceinformation, intake information, symptoms, test results, combinationsthereof, or the like. The information may be shared with any authorizedand/or relevant party such as the ordering provider, other providers forthe patient, payors, insurance providers, PBMs, pharmacies, the patient,caregivers, guardians, combinations thereof, or the like. In exemplaryembodiments, the information may be centralized at one of more databasesat, or associated with, the LIS 108. For example, the information may bestored as it is received at the LIS 108 to build a patient file. Newparties may request access to the patient file, and upon authorization,the patient file may be transmitted or otherwise integrated into therequesting party's system (e.g., a new EHR 104).

FIG. 15A and FIG. 15B illustrate exemplary embodiments of a priorauthorization system 200 in accordance with the present invention whichautomates prior authorization efforts for genetic efficacy testing, suchas with dispensation of pharmaceuticals. Similar items may be numberedsimilarly but increased by 100 (e.g., 102 to 202, etc.). Exemplary logicfor operating the system 200 is provided at FIG. 16A and FIG. 16B.Orders for medications may be received at a pharmacy system 224associated with one or more dispensing pharmacies. The orders may beelectronically transmitted from the healthcare provider's office system202 in exemplary embodiments, such as by way of an electronic healthrecord (“EHR”) system 204, or may be delivered by the patient 216 inother exemplary embodiments. The pharmacy system 224 may be configuredto transmit requests for coverage for the prescribed medications to apharmacy benefits manager (“PBM”) system and/or other payor system 222as shown in FIG. 15A, for example without limitation. The PBM system 222may be configured to forward certain claim information onto thelaboratory information system (“LIS”) 208 associated with the laboratory206 to determine coverage, such as shown in FIG. 15B for example withoutlimitation. The payor system 222 and/or the LIS 208 may be configured toquery one or more databases 223 comprising policy rules related to themedications for which coverage is requested. The coverage decisions maybe processed by a pre-approval request engine 209 at the payor system222 or at the LIS 208. Such approvals or denials may be made, at leastin part, based on patient data retrieved from the EHR 204 andtransmitted to the payor system 222 and/or the LIS 208, though such isnot required.

The LIS 208 and/or payor system 222 may be configured to identify any ofthe prescribed medications which are associated with available geneticefficacy testing. This may be determined by querying one or moredatabases 225 comprising information regarding medications associatedwith available genetic efficacy tests. The one or more databases may beprovided with the one or more databases 223 with policy information orseparate therefrom. The availability of such genetic efficacy testingmay be determined by the LIS 208 in exemplary embodiment, though such isnot required.

The LIS 208 and/or payor system 222 may be configured to determine ifmedications ordered are approved or denied under policy rules applicablefor the respective patient 216. Such a determination may be made by wayof the pre-approval request engine 209 based on information retrievedfrom the database(s) 223 and/or EHR systems 204. Where the medication isotherwise approved, the pre-approval request engine 209 may beconfigured to determine if genetic efficacy testing is available for themedication. The LIS 208 and/or payor system 222 may be configured todetermine if genetic efficacy data is available for medications ordered.Such a determination may be made by way of the pre-approval requestengine 209 based on information retrieved from the database(s) 225. Theanalysis regarding approval under policy rules and the availability ofgenetic efficacy testing may be performed in parallel or in sequence.

Where a determination is made that the medication is covered and thatgenetic efficacy testing is available, the pre-approval request engine209 may be configured to generate an approval decision with a priorauthorization for the associated genetic efficacy testing. The approvaldecision with the prior authorization may be electronically transmittedto the pharmacy system 224 so that the medication can be filled. Thepharmacy system 224 may be configured to electronically notify thedispensing pharmacy of the prior authorization such that the medicationis dispensed to the patient 216 with notice of the prior authorizedgenetic efficacy testing, potentially required for future fills of themedication.

The prior authorization may include a notice to the patient 216 thatcontinued coverage for future fills of the medication, such as refillsor new prescriptions for the same medication, are contingent oncompletion of the pre-approved genetic efficacy testing. Thepre-approval may be authorized for a period of time and/or number ofrefills such that a limited supply of medication may be dispensed underinsurance coverage, so that the patient 216 can begin treatment, beforerequiring the results of genetic efficacy testing. For example, withoutlimitation, the prescription may be refilled 3 times, and/or remainapproved for 60 days. Where the patient 216 fails to undertakes suchtesting, the LIS 208 and/or payor system 222 may be configured to denyfuture coverage request for the medication.

In other exemplary embodiments, future fills of the medication are notdependency on completion on the genetic efficacy testing and the patient216 may be requested or encouraged to voluntarily complete the geneticefficacy testing. In such embodiments, the prior authorization generatedby the LIS 208 and/or the PBM 222 may comprise information about thegenetic efficacy testing and/or information regarding financial or otherincentive for completion such as cash, coupons, policy discounts,combinations thereof, or the like. The LIS 208 and/or the PBM 222 may beconfigured to automatically generate such incentive and electronicallytransmit them to the patient 216 upon receipt of authorization or otherinformation needed for testing to begin.

Where the patient 216 undertakes the testing and the results indicatethat the medication is undereffective or ineffective for the patient,the LIS 208 and/or payor system 222 may be configured to flag suchmedication as an allergy at the EHR 204. Alternatively, or additionally,the LIS 208 and/or payor system 222 may be configured to deny futurecoverage requests for the medication. Alternatively, or additionally,the LIS 208 and/or payor system 222 may be configured to suggestalternative medications or treatment options. Where the patient 216undertakes the testing and the results indicate that the medication iseffective for the patient 216, the LIS 208 and/or payor system 222 maybe configured to approve further fills of the medication.

In exemplary embodiments, the pre-approval process may be as shownand/or described herein, such as but not limited to with respect to atleast FIGS. 5A-5B and/or 9-11. In exemplary embodiments, testing resultsmay be processed as shown and/or described herein, such as but notlimited to with respect to at least FIGS. 6A-7 and/or 12. In exemplaryembodiments, information may be transmitted as shown and/or describedherein, such as but not limited to with respect to at least FIGS. 2-4Band/or 13-14.

Any embodiment of the present invention may include any of the optionalor preferred features of the other embodiments of the present invention.The exemplary embodiments herein disclosed are not intended to beexhaustive or to unnecessarily limit the scope of the invention. Theexemplary embodiments were chosen and described in order to explain theprinciples of the present invention so that others skilled in the artmay practice the invention. Having shown and described exemplaryembodiments of the present invention, those skilled in the art willrealize that many variations and modifications may be made to thedescribed invention. Many of those variations and modifications willprovide the same result and fall within the spirit of the claimedinvention. It is the intention, therefore, to limit the invention onlyas indicated by the scope of the claims.

Certain operations described herein may be performed by one or moreelectronic devices. Each electronic device may comprise one or moreprocessors, electronic storage devices, executable softwareinstructions, and the like configured to perform the operationsdescribed herein. The electronic devices may be general purposecomputers of specialized computing device. The electronic devices may bepersonal computers, smartphone, tablets, databases, servers, or thelike. The electronic connections described herein may be accomplished bywired or wireless means. The computerized hardware, software,components, systems, steps, methods, and/or processes described hereinmay serve to improve the speed of the computerized hardware, software,systems, steps, methods, and/or processes described herein.

What is claimed is:
 1. A system for automating preauthorization ofgenetic efficacy testing with prescription dispensation, said systemcomprising: one or more databases comprising data indicating medicationsfor which genetic efficacy testing is available and policy rules for oneor more payors; a number of pharmacy systems, each associated with oneor more dispensing pharmacies; a prior authorization engine comprisingsoftware instructions stored at one or more electronic storage devices,which when executed, configures one or more processors to: receivecoverage requests for medications from the number of pharmacy systems;query said one or more databases to retrieve policy rules for patientsassociated with each respective one of said coverage requests; querysaid one or more databases to retrieve information regarding whethergenetic efficacy testing is available for said medications in saidcoverage requests; determine if coverage is otherwise available for eachof said received coverage requests as part of a coverage decisionanalysis in accordance with said retrieved policy rules; determine ifgenetic efficacy testing is available, as part of said coverage decisionanalysis, for at least said medications in said coverage requests wherea determination is made that coverage is otherwise available; and foreach of said coverage requests where said coverage decision analysisindicates that coverage is otherwise available and genetic efficacytesting is available for the medication: automatically generate anelectronic prior authorization for said genetic efficacy testing inassociation with said coverage decision; and transmit an approval ofcoverage decision, along with said prior authorization for geneticefficacy testing, to each requesting ones of said number of pharmacysystems from which said coverage requests is received.
 2. The system ofclaim 1 wherein: said prior authorization engine is configured toprovide a denial of coverage decision where said medications associatedwith said coverage requests are not otherwise approved for coverage. 3.The system of claim 2 wherein: said prior authorization engine isconfigured to provide said approval of coverage decision where saidmedications associated with said coverage requests are otherwiseapproved for coverage and said genetic efficacy testing is not availablefor said associated medication.
 4. The system of claim 3 wherein:Prescription Dispensation said prior authorization includes anindication of a period of time or number of refills for said medicationassociated with said coverage decision in which said genetic efficacytesting must be performed for further coverage to be approved.
 5. Thesystem of claim 4 further comprising: a number of electronic healthrecord (“EHR”) systems, each associated with one or more respectivehealthcare providers; and additional software instructions stored at theone or more electronic storage devices, which when executed, configuresthe one or more processors to, where said prior authorization forgenetic efficacy testing has been previously provided from said priorauthorization engine: query said one or more EHR systems to determine ifresults of said genetic efficacy testing are present; and provide anapproval of coverage decision for additional fills of said medicationwhere results of said genetic efficacy testing are found and indicatethat said associated medication is not undereffective or ineffective forsaid respective patient.
 6. The system of claim 5 further comprising:additional software instructions stored at the one or more electronicstorage devices, which when executed, configures the one or moreprocessors to, where said prior authorization for genetic efficacytesting has been previously provided from said prior authorizationengine: query said one or more EHR systems to determine if results ofsaid genetic efficacy testing are provided; and provide a denial ofcoverage decision for additional fills of said associated medicationwhere results of said genetic efficacy testing are not found, or arefound and indicate that said associated medication is undereffective orineffective for said respective patient.
 7. The system of claim 6further comprising: a laboratory information system (“LIS”) associatedwith a laboratory, wherein said pre-approval request engine is providedat said LIS.
 8. The system of claim 6 further comprising: a pharmacybenefits manager (“PBM”) system associated with a PBM, wherein saidpre-approval request engine is provided at said PBM system.
 9. Thesystem of claim 7 further comprising: a genetic sequencing machine inelectronic communication with the LIS; and software instructions storedat one or more electronic storage devices of said LIS, which whenexecuted, configure one or more processors of the LIS to: receive anorder for at least one of the one or more of said genetic efficacy testsfor a respective one of the patients; generate instructions to performthe ordered tests; transmit said instructions to the genetic sequencingmachine; receive genetic testing results comprising genetic markers forthe respective patient from the genetic sequencing machine; query theone or more databases, at least some of which comprise data regardingmedications known to have reduced or no efficacy in persons havingparticular genetic markers, to determine whether any active medicationsin the retrieved active medications are known to have reduced or noefficacy in persons having the same genetic markers as the particularpatient; and transmit a report to each of the EMR systems associatedwith the respective patient indicating all of the active medications forthe respective patient known to have reduced or no efficacy in personshaving the same genetic markers as the respective patient.
 10. Thesystem of claim 9 wherein: said LIS is configured to report said resultsof said genetic efficacy testing to said pre-approval request engine andeach of said number of EHR systems associated with said respectivepatient with instructions sufficient to cause each of said number of EHRsystems associated with said respective patient to flag each of saidundereffective of ineffective medication as an allergy in each of saidnumber of EHR systems associated with said respective patient.
 11. Thesystem of claim 10 wherein: said pre-authorization request engine isconfigured to query each of the number of EHR systems associated withsaid respective patient to retrieve insurance information, activemedications, and diagnoses associated with a particular patient as partof said coverage decision analysis.
 12. The system of claim 11 wherein:said coverage decision analysis comprises medically necessary criteria.13. The system of claim 12 further comprising: a healthcare informationexchange interposed between said LIS and each of said number of EHRsystems.
 14. The system of claim 10 further comprising: an alternativemedication database comprising a list of alternative treatment options,each of which is associated with one or more medications; and additionalsoftware instructions stored at the one or more electronic storagedevices of the LIS, which when executed, configure the one or moreprocessors of the LIS to: query the alternative medication database toretrieve alternative treatment options associated medications matchingthe active medications in the retrieved active medications known to havereduced or no efficacy in persons having the same genetic markers as theparticular patient; and transmit each of the retrieved alternativemedications as part of the report.
 15. A method for automatingpreauthorization of genetic efficacy testing with prescriptiondispensation, said method comprising the steps of: electronicallyreceiving a coverage request for a medication from a pharmacy system;electronically querying a policy rules database to retrieve policy rulesassociated with said coverage request; electronically querying one ormore EHR systems to retrieve patient data for a patient associated withsaid coverage request; automatically and electronically performing, byway of a prior authorization engine, a coverage decision analysis forsaid coverage request using said retrieved policy rules and saidretrieved patient data; electronically providing a coverage decision forsaid coverage request in accordance with said coverage decisionanalysis; electronically determining that said medication for saidcoverage request is otherwise approved for coverage; electronicallyquerying a testing availability database to determine that geneticefficacy testing is available for said medication; automatically andelectronically generating an electronic approval of coverage decisionfor said medication; automatically and electronically generating anelectronic prior authorization for genetic efficacy testing for saidmedication; electronically transmitting said approval of coveragedecision with said prior authorization for genetic efficacy testing tosaid pharmacy system; and notifying said patient of said priorauthorization with dispensation of said medication.
 16. The method ofclaim 15 further comprising the steps of: electronically receiving acoverage request for additional fills of said medication; electronicallyquerying said one or more EHR systems for results of said geneticefficacy testing described in said prior authorization; electronicallydetermining that results of said genetic efficacy testing are found andindicate that said medication is not undereffective or ineffective forsaid respective patient; and automatically and electronically generatingan approval of coverage decision for said additional fills of saidmedication.
 17. The method of claim 15 further comprising the steps of:electronically receiving a coverage request for additional fills of saidmedication; electronically querying said one or more EHR systems forresults of said genetic efficacy testing described in said priorauthorization; electronically determining that results of said geneticefficacy testing are not found or are found and indicate that saidmedication is undereffective or ineffective for said respective patient;and automatically and electronically generating a denial of coveragedecision for said additional fills of said medication.
 18. The method ofclaim 17 further comprising the steps of: electronically receiving, atthe one or more EHR systems, a report comprising said results of saidgenetic efficacy testing, where said results indicate that saidmedication is undereffective or ineffective for said respective patient;and electronically flagging said medication as an allergy at said one ormore EHR systems.
 19. The method of claim 18 wherein: said priorauthorization engine is provided at a laboratory information system(“LIS”) associated with a laboratory; and said LIS is configured togenerate said report with said results.
 20. A system for automatingpreauthorization of genetic efficacy testing with prescriptiondispensation, said system comprising: a number of electronic healthrecord (“EHR”) systems, each associated with one or more respectivehealthcare providers, wherein each of said number of EHR systemscomprises patient data for a respective number of patients; one or morepolicy databases comprising policy rules for one or more respectivepayors; one or more testing availability databases comprisingmedications for which genetic efficacy testing is available; a number ofpharmacy systems, each associated with a respective pharmacy; a pharmacybenefits manager (“PBM”) system associated with a PBM and said number ofpharmacy systems; a laboratory information system (“LIS”) associatedwith a laboratory; one or more genetic sequencing machines in electroniccommunication with the LIS; and a prior authorization engine, located atthe LIS, and comprising software instructions stored at one or moreelectronic storage devices, which when executed, configures one or moreprocessors to: receive coverage requests for medicines from the PBMsystem as provided to the PBM from the number of pharmacy systems; querysaid one or more policy databases to retrieve policy rules associatedwith each respective one of said coverage requests; query said one ormore EHR systems to retrieve patient data for patients associated witheach respective one of said coverage requests; provide initial coveragedecisions for each respective one of said coverage requests inaccordance with said retrieved policy rules and said retrieved patientdata for each respective one of said coverage request; where saidinitial coverage decisions indicate that associated medications are nototherwise approved for coverage provide a denial of coverage decision;where said initial coverage decisions indicate that associatedmedications are otherwise approved for coverage: query said one or moretesting availability databases to determine if genetic efficacy testingis available for said associated medications; where said geneticefficacy testing is not available for said associated medications,automatically generate an approval of coverage decision; where suchgenetic efficacy testing is available for said associated medications,automatically generate said approval of coverage decision and a priorauthorization for said available genetic efficacy testing, where saidprior authorization includes a period of time or number of refills forsaid medication associated with said coverage decision in which saidgenetic efficacy testing must be performed; and transmit said approvalor denial of coverage decisions, along with any prior authorization forgenetic efficacy testing, to said PBM system and requesting ones of saidnumber of pharmacy systems; receive requests for additional fills ofsaid medications; determine if said approval of coverage decision wasissued for said medications for which additional fills are requested,and whether said approval of coverage decision included said priorauthorization for genetic efficacy testing, and if so: query said one ormore EHR systems to determine if results of said genetic efficacytesting are present; and provide said approval of coverage decision forsaid additional fills of said associated medication where results ofsaid genetic efficacy testing are found and indicate that saidassociated medication is not undereffective or ineffective for saidrespective patient; and provide said denial of coverage decision forsaid additional fills of said associated medication where results ofsaid genetic efficacy testing are not found, or are found and indicatethat said associated medication is undereffective or ineffective forsaid respective patient.